Conditioning Electrical Stimulation to Improve Outcomes in Carpal Tunnel Syndrome
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|ClinicalTrials.gov Identifier: NCT04191538|
Recruitment Status : Recruiting
First Posted : December 9, 2019
Last Update Posted : July 13, 2022
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Carpal tunnel syndrome is common, identified in 3% of the general population. Symptoms including numbness and pain are due to compression of the median nerve as it travels through a tunnel entering the wrist and can result in weakened grip strength and poor dexterity. Despite surgical release, nerve damage due to chronic compression often cannot be completely reversed, with resulting sensorimotor deficits. Postoperative electrical stimulation (ES) has been well-reported to improve nerve regeneration and is currently standard of practice at our institution. Investigators of this study have recently shown in an animal model that by changing the timing of the ES from postoperative to preoperative, this "conditioning" electrical stimulation (CES) significantly improves nerve regeneration.
Patients with severe carpal tunnel syndrome will be identified in plastic surgery clinics. Patients who consent to participating will undergo baseline testing including nerve conduction studies, sensory evaluation, motor testing, and patient-reported outcomes. Participants will be randomized to three groups: i) CES, ii) postoperative ES, and iii) no ES. CES will be delivered in clinic by placing a percutaneous needle alongside the median nerve, and stimulation will be delivered for one hour, with patient comfort dictating the voltage of stimulation. At the completion of one hour, the needle will be removed, and a standard carpal tunnel release will be performed by their plastic surgeon 4-7 days later. Patients will the second cohort will undergo postoperative ES immediately following their carpal tunnel release, using the same stimulation parameters as CES. The third cohort will receive only carpal tunnel release without stimulation.In all patients, sensory and motor reinnervation, using the same testing modalities as preoperative assessment, will be evaluated at 3, 6, and 12 months post-operative.
|Condition or disease||Intervention/treatment||Phase|
|Carpal Tunnel Syndrome||Procedure: Conditioning electrical stimulation Procedure: Postoperative electrical stimulation Procedure: No electrical stimulation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized control trial|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Patients will be randomized by an objective third party, who will provide electrical stimulation at the appropriate time given randomized cohort. Patients, surgeon, and investigator will be unaware of arm of study.|
|Official Title:||Conditioning Electrical Stimulation to Improve Outcomes in Carpal Tunnel Syndrome|
|Actual Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||December 30, 2022|
|Estimated Study Completion Date :||January 1, 2023|
Experimental: Conditioning electrical stimulation
Patients will receive percutaneous electrical stimulation one week prior to carpal tunnel release. They will receive sham stimulation immediately after surgery to ensure blinding.
Procedure: Conditioning electrical stimulation
Percutaneously, a small needle will be placed alongside the median nerve. Patients will receive 1 hour of 20Hz stimulation with voltage titrated to maintain patient comfort.
Active Comparator: Postoperative electrical stimulation
Patients will receive electrical stimulation immediately following carpal tunnel release, per out previous studies. They will receive sham stimulation 1 week prior to surgery to ensure blinding.
Procedure: Postoperative electrical stimulation
Immediately following carpal tunnel release, needles for electrical stimulation will be placed alongside the visualized median nerve. Patients will receive 1 hour of 20Hz stimulation with voltage titrated to maintain patient comfort.
Sham Comparator: No electrical stimulation
Patients will not receive electrical stimulation. They will receive electrical stimulation before and after surgery to ensure blinding.
Procedure: No electrical stimulation
Patients will receive sham stimulation (needles placed, no current delivered) pre- and post-operatively; however, no current will ever be delivered to the nerve. This is the control cohort.
- Sensory reinnervation [ Time Frame: Compare with baseline function to that at 12 months ]Patients will be tested for 2-point discrimination and touch (Semmes-Weinstein filaments)
- Motor reinnervation [ Time Frame: Compare with baseline function to that at 12 months ]Purdue Pegboard Test
- Patient-reported outcome [ Time Frame: Compare with baseline function to that at 12 months ]Disabilities of the Arm, Shoulder and Hand questionnaire
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Severe carpal tunnel syndrome (per screening nerve conduction test - thenar motor unit loss minimum two standard deviations between the mean for the age group)
- Failed conservative treatment (requires surgical intervention)
- Preexisting neuropathy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04191538
|Contact: Ming Chan, MD, FRCPC||(780) email@example.com|
|University of Alberta||Recruiting|
|Edmonton, Alberta, Canada|
|Contact: Jenna-Lynn Senger, MD (780) 906-7221 firstname.lastname@example.org|
|Principal Investigator: Ming Chan, MD, FRCPC|
|Responsible Party:||Ming Chan, Professor, University of Alberta|
|Other Study ID Numbers:||
CES of CTS
|First Posted:||December 9, 2019 Key Record Dates|
|Last Update Posted:||July 13, 2022|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||All data collected will be de-identified and no individual information will be released.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Carpal Tunnel Syndrome
Peripheral Nervous System Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries